510(k) · Cleared
ClearedRespironics Simplyclear Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Respironics, Inc. · SDT Intra-Pulmonary Percussive Vibration (Ipv) Devices
Cleared on Dec 31, 2012 as substantially equivalent to K024309 (Advanced Respiratory, 2003) and 3 other predicates after a 167-day review. Its family tree reaches back 5 generations to 1988. 4 later devices descend from it.
- Decided
- Dec 31, 2012
- Review
- 167 days
- Class
- Class II
- Product code
- SDT
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 5 generations to K884098 (1988). 8 ancestors in all. 4 later devices descend from it, 3 citing it directly.
- Root · 5 generations backK884098 Thairapy (TM) Bronchial Drainage System, Model 101American Biosystems, Inc. · 1988
- 4 generations backK965192 Thairapy Vest SystemAmerican Biosystems, Inc. · 1997
- 3 generations backK993629 Abi Vest Airway Clearance SystemAmerican Biosystems, Inc. · 2000
- 2 generations backK012928 Abi Vest Airway Clearance SystemAdvanced Respiratory · 2001
- 1 generation backK024309 The Vest Airway Clearance System, Model 104Advanced Respiratory · 2003
- This deviceK122111 Respironics Simplyclear DeviceRespironics, Inc. · 2012
- Descendant · cites it directly · 1 of its ownK140598 Pegaso Cough, Pegaso a-Cough, Pegaso a-Cough PercDima Italia Srl · 2014
- Descendant · 2 generations on · 0 of its ownK253001 KT Airway Clearance Device II (KT-3); KT Airway Clearance Device II…Hunan Ruijiong Biotech Co., Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK241091 SIMEOX 200 Airway Clearance DeviceInogen, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK140605 Minipegaso Cough, Minipegaso a-Cough, Minipegaso a-Coug PercDima Italia Srl · 2014
Most influential descendants
Showing 4 of 4 · See all- K140598Pegaso Cough, Pegaso a-Cough, Pegaso a-Cough PercDima Italia Srl · 2014 · cites it directly1descendant
- K253001KT Airway Clearance Device II (KT-3); KT Airway Clearance Device II (KT-5)Hunan Ruijiong Biotech Co., Ltd. · 2026 · 2 generations on0descendants
- K241091SIMEOX 200 Airway Clearance DeviceInogen, Inc. · 2024 · cites it directly0descendants
- K140605Minipegaso Cough, Minipegaso a-Cough, Minipegaso a-Coug PercDima Italia Srl · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K884098 | Thairapy (TM) Bronchial Drainage System, Model 101 | American Biosystems, Inc. | 1988 | — |
| −4 | K965192 | Thairapy Vest System | American Biosystems, Inc. | 1997 | — |
| −3 | K993629 | Abi Vest Airway Clearance System | American Biosystems, Inc. | 2000 | — |
| −2 | K012928 | Abi Vest Airway Clearance System | Advanced Respiratory | 2001 | — |
| −1 | K024309 | The Vest Airway Clearance System, Model 104 | Advanced Respiratory | 2003 | — |
| 0 (this device) | K122111 | Respironics Simplyclear Device | Respironics, Inc. | 2012 | — |
| +1 | K140598 | Pegaso Cough, Pegaso a-Cough, Pegaso a-Cough Perc | Dima Italia Srl | 2014 | — |
| +2 | K253001 | KT Airway Clearance Device II (KT-3); KT Airway Clearance Device II (KT-5) | Hunan Ruijiong Biotech Co., Ltd. | 2026 | — |
| +1 | K241091 | SIMEOX 200 Airway Clearance Device | Inogen, Inc. | 2024 | — |
| +1 | K140605 | Minipegaso Cough, Minipegaso a-Cough, Minipegaso a-Coug Perc | Dima Italia Srl | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2008 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 2 | 0 |
| 2024 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in SDT? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new SDT device
- #1 K241091 SIMEOX 200 Airway Clearance Devicescore 10.1 · 6 generations · no Class I recall
What was it cleared against? (4)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K024309 | The Vest Airway Clearance System, Model 104Summary page 6…standards). Predicate Device Name(s) and Modified Vest AirwayTM Clearance System - 5 10(k) numbers: K024309 Emerson CoughAssist, Model CA-3000 - K002598… | 2003 |
| * | K002598 | Emerson Cough Assist Model CA-3000 W/Automatic Timing and Model CM-3000 W/Manual TimingSummary page 6…10(k) numbers: K024309 Emerson CoughAssist, Model CA-3000 - K002598 Dima Italia Negavent DA-3 Plus Pegaso - K072… | 2000 |
| * | K072292 | Negavent Plus Pegaso Cough, Model: DA-3 PlusSummary page 6…K002598 Dima Italia Negavent DA-3 Plus Pegaso - K072292 Philips Respironics CoughAssist T70 - K12 1955 Reason for submission:… | 2008 |
| * | K121955 | Coughassist T70 Device Cleared while this submission was under review Summary page 6…ima Italia Negavent DA-3 Plus Pegaso - K072292 Philips Respironics CoughAssist T70 - K12 1955 Reason for submission: New Device Description of Device: The Philips Respironics SimplyClear device promot… | 2012 |
What descends from it? (4)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 24 years and passes through 3 companies; a new generation was cleared every 2.6 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K140598 (Dima Italia Srl, 2014) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K024309.
How does its category compare?
All SDT devicesSDT Intra-Pulmonary Percussive Vibration (Ipv) Devices: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · SDT
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · SDT
Too few SDT 510(k)s in any year since 2007 to give a median.
Recalls per year · SDT
No recall names SDT since 2007.
Adverse event reports per year · SDT
No MAUDE report names SDT since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Philips Respironics SimplyClear device promotes airway clearance by gradually applying air pulse generated high frequency oscillatory vibrations on the positive and negative pressures applied to the chest wall via the airways. The high frequency oscillatory vibrations release mucus from the bronchial walls, increasing mobilization. The shift in pressure produces a high expiratory flow from the lungs, promoting the clearance of the mobilized…
Read the full statement (124 words)
The Philips Respironics SimplyClear device promotes airway clearance by gradually applying air pulse generated high frequency oscillatory vibrations on the positive and negative pressures applied to the chest wall via the airways. The high frequency oscillatory vibrations release mucus from the bronchial walls, increasing mobilization. The shift in pressure produces a high expiratory flow from the lungs, promoting the clearance of the mobilized secretions via coughing.
The Philips Respironics SimplyClear device may be used either with a facemask or mouthpiece, or with an adapter to a paticnt’s endotracheal or tracheostomy tube. It is for use on adult or pediatric patients having difficulty with secretion clearance and/or inability to cough.
The SimplyClear device is for use in a hospital, institutional environment or in the home.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K122111 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122111: Respironics Simplyclear Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122111
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026